COMPARISON OF ADVERSE EVENT PROFILE OF TEGASEROD WITH THE OTHER DRUGS CURRENTLY AVAILABLE IN THE MARKET USING FAERS DATABASE 2000 - 2015

Author(s)

Gangal NS, Guo JJ
University of Cincinnati, Cincinnati, OH, USA

OBJECTIVES: The discussion around the cardiovascular risk caused by Tegaserod continues, as the results from previous studies were believed inconclusive. The objective of this study is to describe the adverse events especially cardiovascular events associated with Tegaserod and other four common drugs used to treat irritable bowel syndrome.  METHODS: FDA AERS database was used for data analysis; reports were drawn from years 2000 to 2015. The study include 5 drugs: Tegaserod, Alosetron, Lubiprostone, Linaclotide, and Prucalopride. A secular trend of annual total number of adverse events was calculated.  Patient’s mean age and sex distribution were compared between study drugs.  Different patient outcomes associated with each drug were quantified. Total number of cardiovascular related events was compared for each drug. SAS version 9.3 were used to analyze the FAERS datasets.  RESULTS: Tegaserod was associated with the highest number of adverse events which peaks at the year 2007 exactly when the drug was suspended from the market.Females had significantly more adverse events reported. Tegaserod caused most hospitalizations and other outcomes followed by Lubiprostone. Tegaserod was also associated with higher percentage of disability, death and life thretning events. Abdominal pain, nausea and vomitting were most common side effects caused. Tegaserod caused chest pain which was ranked second and contributed 1.46% . Tegaserod was associated with sigificantly higher number (5559, 11.5%) of cardiovascular events followed by Lubiprostone (1322, 6.90%).  Prucalopride had least number of events (18, 4.37%) while Alosetron was associated with least percent of cardiovascular events (376, 1.97%). CONCLUSIONS: Tegaserod was associated with significantly more and severe adverse events, especially cardiovascular events compared to other four drugs.

Conference/Value in Health Info

2016-05, ISPOR 2016, Washington DC, USA

Value in Health, Vol. 19, No. 3 (May 2016)

Code

PGI2

Topic

Epidemiology & Public Health

Topic Subcategory

Safety & Pharmacoepidemiology

Disease

Gastrointestinal Disorders

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